A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.
Vaccine
; 36(52): 7943-7949, 2018 12 18.
Article
em En
| MEDLINE
| ID: mdl-30420116
ABSTRACT
BACKGROUND:
A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency.METHODS:
This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given at 6, 10, and 14â¯weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards.RESULTS:
The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B 1.07; Lot A versus Lot C 1.06; and Lot B versus Lot C 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.CONCLUSION:
Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
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2_ODS3
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3_ND
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4_TD
Problema de saúde:
1_doencas_transmissiveis
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2_enfermedades_transmissibles
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3_diarrhea
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4_diarrhoeal_infections
Assunto principal:
Vírus Reordenados
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Vacinas contra Rotavirus
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Imunogenicidade da Vacina
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Anticorpos Antivirais
Tipo de estudo:
Clinical_trials
Limite:
Animals
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Female
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Humans
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Infant
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Male
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Índia